Study Start-Up Specialist (Site Management Associate II)

🤩 Do you like the dynamics of start-up? 🤩

Are you looking for a new challenge and would like to work for a single sponsor?

For one of our clients, located in the region of 📍Amsterdam (Netherlands), we are looking for a new team member to join their start-up division. Our client is a biotech company with innovative treatment in oncology.

By joining ICON as a Start-Up Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

The Study Start-Up Specialist is responsible for supporting Site Start-Up activities, including collection and review of essential documents, and reviewing and approving Informed Consent Forms (ICFs) for ethics committee submissions.

What your day will look like:

• You will be busy sending e-mails, making calls to resolve querries and to assist in the submissions, as you serve as the primary point of contact for the start-up of the site; 🙋🏼‍♀️ 📞 📩
• Making sure that start-up packets are sent;
• Acting as the Informed Consent Specialist  by reviewing and approving the most important patient document;
• You will collect, review, approve and track essential documents;
• Interact with the start-up team (SSU Managers) by providing regular updates;
• Assist in weekly start-up meetings with different stakeholder;
• Forecast and track metrics; 📈
• Make sure the archiving is done adequately: essential documents are uploaded in the Trial Master File 🖥️

In order for you to be succesfull in ths role, you have

• Minimum of 4 years of exerpeince in clinical trials in a pharma, biotecht or CRO environment

• Bachelor or Master degree in Life Sciences (Biomedical, Nursing, Pharmacy, Medical Management Assistant,...) 👩‍🎓 

• By preference minimum of 1 year of experience in managing (independently) ethics committee submissions and experience with the ICF

• ICH-GCP knowledge 📒
• Eye for detail: accuracy is everything in clinical research. We have a right the first time mindset! 🔎
• Multitasking skills: you are very organised, whilst managing different tasks
• A independent personality: you are a self-starter and like to learn on the job
• Fluent communication skills in Dutch and English. The level of Dutch needs to be very fluent to native.

Why ICON?

• Exciting projects with our sponsors
• Dedicated line manager at ICON and follow-up by the sponsor
• Continuous learning opportunities 🚀
• Homebased opportunities - flexibility in work-life balance 🏠
• Competitive packages, including company car 🚗

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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